Abstract
Given the rapidly changing health care system and the demands all levels of consumer are placing on the assessment of “value”— the point at which both economic and clinical outcomes are maximized— the evaluation of the market impact of a drug or device has moved to earlier in the development process. For a variety of reasons, however, the ‘“real-life” measurement of a drug's economic impact, in particular, is difficult to assess within the controlled environment of a randomized clinical trial. This paper discusses some of the methodological and practical challenges of conducting trial-based economic studies and suggests ways in which retrospective data can inform and improve the clinical design process. Various data sources that could be used to address several key issues in the design of prospective economic evaluations are presented, including their advantages and limitations. Finally, several sample applications using existing sources of secondary data are presented in order to further operationalize this process.
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